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A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT01802515
First received: February 27, 2013
Last updated: June 13, 2014
Last verified: June 2014

February 27, 2013
June 13, 2014
December 2012
March 2014   (final data collection date for primary outcome measure)
Proportion retained in treatment [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Cumulative probability of an individual's retention in 9 weeks of treatment will be compared between the treatment groups.
Proportion retained in treatment [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Cummulative probability of an individual's retention in 9 weeks of treatment will be compared between the treatment groups.
Complete list of historical versions of study NCT01802515 on ClinicalTrials.gov Archive Site
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A Drug Treatment for Cocaine Users Who Are Also on Methadone Maintenance Treatment
Atomoxetine Treatment for Opioid Maintained Cocaine Users

The main goal of this study is to evaluate the safety and tolerability of 40 or 80 mg atomoxetine as a treatment for cocaine dependence. The Phase I studies summarized above support the safety of atomoxetine in combination with stimulants. As the next step, the investigators will evaluate the safety and tolerability of atomoxetine in a small clinical trial with cocaine users. If atomoxetine is found to be promising in this study and sufficiently powered, double-blind, placebo-controlled studies will be proposed.

This will be an approximately 13 to 14 week double-blind, placebo-controlled clinical trial testing the safety and feasibility of atomoxetine (40 or 80 mg/day) treatment, compared to placebo, in methadone-stabilized stimulant users. The study will have 3 phases: 1) a one to two week- methadone-induction phase; 2) an 8-week "treatment" phase; and 3) 1 week atomoxetine taper and about a 4-week methadone "taper and detoxification or transfer" phase. Subjects will be randomized to three treatment arms: 40 mg (n=15) atomoxetine, or 80 mg (n=15) atomoxetine, or placebo (n=15). During the methadone induction phase, subjects will be stabilized on methadone. During induction onto methadone, participants will be administered increasing doses of methadone starting at 30 mg daily, and this dose will be increased for stabilization of opiate withdrawal symptoms from 40 mg up to 140 mg depending on individual need. Based on the clinic schedule between 1 to 2 weeks after methadone treatment is initiated , atomoxetine treatment will be started at 40 mg/day. For those assigned to 80 mg of atomoxetine, the dose will be titrated up to 80 mg/day on the second week of treatment phase. At the end of the treatment-phase, subjects will undergo detoxification from methadone over a 4-week period based on an individual's needs, and they will concurrently be tapered off atomoxetine. All participants will receive a weekly one-hour of individual psychotherapy (Cognitive Behavioral Therapy) with experienced clinicians specifically trained to deliver the therapy, and who will receive ongoing supervision.

Currently this study is in data analysis phase with 11 completers. (June 2014)

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cocaine Dependence
  • Opiate Dependence
  • Drug: Atomoxetine, low dose
    The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.
    Other Names:
    • Strattera,
    • National Drug Codes - 00002-3229
  • Drug: Atomoxetine, high dose
    The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.
    Other Name: Strattera, National Drug Codes - 00002-3250
  • Drug: Placebo
    The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.
    Other Name: sugar pill
  • Active Comparator: Atomoxetine, low dose
    1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.
    Intervention: Drug: Atomoxetine, low dose
  • Active Comparator: Atomoxetine, high dose
    One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules
    Intervention: Drug: Atomoxetine, high dose
  • Placebo Comparator: Placebo (sugar pill)
    1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • • Men and women between 18 and 65 years old.

    • Current opioid dependence as evidenced by 1) documentation of prior treatment for opioid dependence or signs of withdrawal, 2) self-reported history of opioid dependence for 12 consecutive months and, 3) a positive urine toxicology screen for opiates.
    • Diagnosis of opioid dependence and cocaine dependence by DSM-IV-criteria as well as laboratory confirmation of recent cocaine use in the form of positive urine toxicology during the month prior to study entry.
    • For those who recently participated in a research study, at least 2 weeks of washout period before enrollment.
    • A history of cocaine use,( a minimum of 1/2 gram during the preceding 30 days).
    • Must be seeking treatment for opioid and cocaine use.
    • For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests.

Exclusion Criteria:

  • • Serious medical illnesses including hypertension, tachycardia, bradycardia, or other arrhythmias and major cardiovascular, cerebrovascular, renal, endocrine, or hepatic disorders;

    • Serious psychiatric illness, history of psychosis, schizophrenia or bipolar type I disorder.
    • Current major depression. Subjects with current depressive symptoms not meeting criteria will be included in the study, with the exception of those endorsing suicidal and homicidal thoughts, will be excluded even if full criteria for major depression are not met.
    • Current diagnosis of alcohol or drug dependence other than opiates, cocaine, nicotine and cannabis.
    • Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.
    • Has not been treated with monoamine oxidase inhibitors within the last fourteen days.
    • Liver function tests (ALT or AST) greater than 3 times normal.
    • Known allergy or intolerance to atomoxetine.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01802515
1206010407
Yes
Mehmet Sofuoglu, Yale University
Yale University
Not Provided
Principal Investigator: Mehmet Sofuoglu, M.D,Ph.D. Yale University
Yale University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP